Pilot Study of Galantamine to Treat Metabolic Syndrome in People With Chronic Traumatic Spinal Cord Injury (SCI)

ClinicalTrials.gov ID

NCT07625332

Lead Sponsor

Northwell HealthOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Phase 2Phase 3

Enrollment

60Estimated

Last Update Posted

Jun 4, 2026Actual

Start Date

Jun 15, 2026Estimated

Primary Completion Date

Jun 2027Estimated

Completion Date

Dec 2027Estimated

Official Title

Pilot Study of Tolerability and Preliminary Efficacy of Galantamine to Treat Metabolic Syndrome in People With Chronic Traumatic Spinal Cord Injury (SCI)

Brief Summary

The purpose of this research study is to measure the tolerability and preliminary efficacy of a drug, galantamine, to treat metabolic syndrome (MetS) by reducing circulating inflammation in people with spinal cord injury (SCI). Galantamine is FDA-approved for the treatment of Alzheimer's disease. Here, the drug is considered experimental for the purposes of this study.

• Spinal Cord Injury
• Traumatic Spinal Cord Injury
• Paraplegia and Tetraplegia
• Metabolic Syndrome

• Galantamine Hydrobromide Extended Release

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• Adults aged 21-75 years (male or female)
• Chronic (≥1 year post injury) traumatic non-progressive spinal cord injury (SCI)
• Wheelchair user for community mobility
• Injury level of tetraplegia (cervical level) or paraplegia (all levels)
• SCI-specific obesity indicated by waist circumference ≥94 cm
• Resting heart rate >45 bpm based on 10 measurements over 10 minutes
• Without clinically significant cardiovascular abnormalities as indicated by 12-lead ECG
• Tolerable bowel routine indicated by a score of <10 on the International SCI Bowel Function Data Set (ISCI-BDS)
• Metabolic Syndrome (MetS) defined by the presence of at least three of the following: (1) obesity indicated by SCI-specific waist circumference ≥94 cm, (2) elevated fasting glucose ≥100 mg/dL, (3) dyslipidemia: high triglycerides ≥150 mg/dL or low HDL cholesterol <40 mg/dL for men and <50 mg/dL for women, (4) C-reactive protein (CRP) levels >1 mg/dL
• Able to understand and communicate in English at the level of describing adverse event frequency and severity and completing validated outcome measures
• Willingness to comply with all study procedures and availability for the duration of the study
• Provision of signed and dated informed consent form

Exclusion Criteria:

• Diagnosis of neurological injury or condition other than SCI
• Progressive condition that would be expected to change neurological status
• Signs and symptoms of cardiovascular disease or cardiac arrhythmias
• Resting heart rate <45 bpm
• Score of 10 or greater on the ISCI-BDS v2.1 indicating moderate to severe neurogenic bowel dysfunction
• Severe concurrent medical disease, condition, or illness judged to be contraindicated by the site physician
• Psychopathology documented in the medical record or history that may conflict with study objectives
• Pregnancy (participant reported or determined by clinical lab test), women who plan to become pregnant, or women who are nursing during the study
• Active cancer or currently in treatment for cancer
• Triglyceride levels ≥400 mg/dL
• Chronic use of medications with known or probable interactions with galantamine
• Enrolled in another research study that is likely to interfere with conduct or results of the current study
• Any other reason the site physician feels that participation is contraindicated

Primary Purpose

Treatment

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Northwell HealthOTHER

Collaborators

Bronx Veterans Medical Research Foundation, IncOTHER

Kessler Institute for RehabilitationINDUSTRY

wpello@northwell.edu516-562-1331

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